Intracranial AneurysmSCOPE-AUSNCT03815149
Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms
An observational study of Intracranial Aneurysm and Cerebral Aneurysm, run by Gold Coast Hospital and Health Service at 4 sites in Australia.
Trial summary
This observational, retrospective, single-arm, multi-centre cohort study will use real-world data (RWD) to develop real-world evidence (RWE) of the safety and clinical effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in Australian patients that have received a flow diversion device to… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intracranial Aneurysm, Cerebral Aneurysm, Subarachnoid Hemorrhage
- What is being tested?
- Pipeline™ Flex Embolization Device with Shield Technology™
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 4 sitesAustralia
- Study dates
- 30 May 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population is comprised of Australian patients aged ≥ 18 years that have received Pipeline™ Flex Embolization Devices with Shield Technology™ during a standard of care procedure to treat an IA. The patient selection period extends from 01 April 2015 to 30 June 2018.
Who may be able to join
- Patients ≥ 18 years of age
- Medical records from patients that have received a Pipeline™ Flex Embolization Device with Shield Technology™ inclusive of all indications such as an elective procedure, unscheduled procedure or emergency procedure for an unruptured or ruptured intracranial aneurysm(s) at each study site
- Medical records from patients that have received other neurovascular therapies such as coils, intracranial stents etc. with a Pipeline™ Flex Embolization Device with Shield Technology™ used as an adjunctive device during the index procedure
Who cannot join
- Medical records from patients that have not received a Pipeline™ Flex Embolization Device with Shield Technology™ to treat an intracranial aneurysm
Trial locations and contacts
4 sites in 1 country.
Australia4 sites, 4 recruiting
- Recruiting
Gold Coast University Hospital
Gold Coast, Queensland, 4215
Henry (Hal) A Rice MBBS FRANZCR
Maame Amma P Owusu RN BSc MNurst NVRN-BC, +61 7 5687 6447, maame.owusu@health.qld.gov.au
- Not yet recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Albert Chiu MBBS (Hons) FRANZCR
William McAuliffe MBBS FRANZCR
- Recruiting
Prince of Wales Hospital
Sydney, New South Wales, 2000
Jason D Wenderoth MBBS(Hons 1) FRANZCR
Andrew Cheung BSc MBBS(Hons 1) FRANZCR
- Recruiting
Liverpool Hospital
Sydney, New South Wales, 2170
Nathan Manning BApSci, BSci(Hons), MBBS, FRANZCR, CCINR FRANZCR
Jason Wenderoth MBBS (Hons 1), FRANZCR
About this study
Official title: The Safety and Clinical Effectiveness of Pipeline™ Flex Embolization Devices With Shield Technology™ in Patients With Intracranial Aneurysms: a Multicentre Retrospective Study of an Australian Cohort (SCOPE-AUS)
This observational, retrospective, single-arm, multi-centre cohort study will use real-world data (RWD) to develop real-world evidence (RWE) of the safety and clinical effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in Australian patients that have received a flow diversion device to treat an intracranial aneurysm (IA). The medical records from 500 procedures completed at Gold Coast University Hospital in Queensland (QLD), Prince of Wales Hospital in New South Wales (NSW), and Sir Charles Gardiner Hospital in Western Australia (WA), will be analysed.
The study will report the risk and likelihood of stroke (ischaemic and haemorrhagic), delayed neurological adverse events and incomplete aneurysm occlusion within sub-groups of the patient cohort and determine the predictive or confounding factors that influence clinical outcomes under pragmatic or 'real-world' conditions.
Read the detailed description
Methodology summary: Single-arm, longitudinal, retrospective, multi-centre cohort study. A collaboration of Australian Interventional Neuroradiologists will create a data bank of existing clinical and angiographic data extracted from medical records review. The data collection variables are pre-specified using grading scales and clinical assessment with the greatest reliability or significant to to accurately represent patient cohorts receiving treatment within all indications of use. The study will establish a minimum dataset to collect patient socio-demographics, aneurysm characteristics, device characteristics, and clinical outcomes for up to 500 procedures completed using Pipeline™ Flex Embolization Device with Shield Technology™. A framework for data ab The prevalence, severity and outcomes of neurological adverse events of interest and bleeding events will be reported . Independent physician assessments of complete aneurysm occlusion from completed computed tomography scans (CT), Magnetic Resonance Imaging (MRI) scans and Digital Subtraction Angiography (DSA) procedures will be determined according to the Raymond Roy Occlusion Classification (MRRC), O'Kelly Marotta scale (OKM) for aneurysm occlusion using flow diverting devices and the Consensus grading scale for endovascular aneurysm occlusion up to 12 months post procedure. Assessments of wall apposition and in-stent stenosis (ISS) will also be completed.
Quality Assurance plan includes - Framework data abstraction - manual of procedures, data dictionary, data abstraction manual, desired inter-rater reliability +0.80; intrarater reliability, intraclass correlation coefficient (ICC) 0.75 - 0.9;
Medical imaging review assessed by assess aneurysm occlusion by an independent interventional neuroradiologist or a local physician operator that did not complete the primary procedure. Physician level of agreement - interrater reliability to be reported;
Independent physician review of all post-op strokes (ischaemic, haemorrhagic) cases to determine aetiology/mechanism;
Study personnel training; Site visits; remote data monitoring, data audits.
Statistical analysis plan include descriptive statistics and regression models to report prevalence, mortality, time-to-event analyses and estimations of risk; Counts of medical records with insufficient data for analysis or where the patient is identified as 'lost follow-up', this will be reported.
- Conditions
- Intracranial Aneurysm, Cerebral Aneurysm, Subarachnoid Hemorrhage, Stroke, Acute, Cerebral Hemorrhage, Cerebral Stroke
- Being tested
- Pipeline™ Flex Embolization Device with Shield Technology™
- Keywords
- Interventional Neuroradiology, Diagnostic neuroradiology, Neurosurgery, Neurovascular Devices, Flow Diversion Device
- Medical subject headings
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Stroke, Cerebral Hemorrhage, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pipeline™ Flex Embolization Device with Shield Technology™Device
Also called Neurointerventional procedure
Neurointerventional procedures to treat intracranial (cerebral) aneurysms are minimally-invasive procedures performed by Interventional Neuroradiologists. The physician accesses the arterial system through a blood vessel in the groin followed by the insertion of a catheter. Pipeline™ Flex Embolization Device(s) with Shield Technology™,a flow diversion device, is implanted under high-magnification subtraction fluoroscopy, requiring the use of ancillary devices, such as micro-catheters and guidewires to complete the procedure under general anaesthetic. Procedural heparinisation and preloading with dual antiplatelet therapy (DAPT) using acetyl-salicylic acid and P2Y12 inhibitors such as clopidogrel or prasugrel are required.
| Study group | Role | What they receive |
|---|---|---|
| patients with intracranial aneurysm(s) | Standard of care elective, unscheduled or emergency procedures for the treatment of an unruptured or ruptured intracranial aneurysm(s) using a Pipeline™ Flex Embolization Device(s) with Shield Technology™ Receives: Device: Pipeline™ Flex Embolization Device with Shield Technology™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of stroke (short-term)
Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
Measured: 30 days
Mortality due to stroke (short-term)
Number of deaths due to ischaemic and haemorrhagic post procedure
Measured: 30 days
Morbidity due to neurological adverse events of interest (short-term)
Prevalence of neurological adverse events of interest post procedure
Measured: 30 days
Prevalence of stroke (long-term)
Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
Measured: 12 months
Morbidity due to neurological adverse events of interest (long-term)
Prevalence of neurological adverse events of interest post procedure
Measured: 12 months
Mortality due to stroke (long-term)
Number of deaths due to ischaemic and haemorrhagic post procedure
Measured: 12 months
Mortality due to neurological adverse events of interest (long-term)
Deaths due to other neurological adverse events of interest
Measured: 12 months
All cause mortality
Deaths due to any cause
Measured: 12 months
Secondary outcomes (11)
Aneurysm occlusion - Wall apposition
Proportion of aneurysms with good wall apposition at post-operative time point
Measured: Day 0
Aneurysm occlusion - Consensus grading scale for endovascular occlusion (short-term)
Proportion of aneurysms with Grade 0 - 5 aneurysm occlusion; Grade 0 is complete aneurysm occlusion (better outcome; maximum score) Grade 5 is less than 25% aneurysm occlusion (worse outcome; minimum score)
Measured: 6 months
Aneurysm occlusion - Consensus grading scale for endovascular occlusion (long-term)
Proportion of aneurysms with Grade 0 - 5 aneurysm occlusion; Grade 0 is complete aneurysm occlusion (better outcome; maximum score) Grade 5 is less than 25% aneurysm occlusion (worse outcome; minimum score)
Measured: 12 months
Aneurysm occlusion - O'Kelly Marotta Scale (OKM; short-term)
Proportion of aneurysms with Grade D1 aneurysm occlusion on the O'Kelly Marotta Scale. Grade D1 indicates completed aneurysms occlusion as seen on the arterial phase of the cerebral angiogram due to 0% filling (better outcome; maximum score). Grade A1 represents total filling of the aneurysm (>95%) as seen on the arterial phase of the cerebral angiogram (worse outcome; minimum score).
Measured: 6 months
Aneurysm occlusion - O'Kelly Marotta Scale (OKM; long-term)
Proportion of aneurysms with Grade D1 aneurysm occlusion on the O'Kelly Marotta Scale; Grade D1 indicates completed aneurysms occlusion as seen on the arterial phase of the cerebral angiogram due 0% filling (better outcome; maximum score). Grade A1 represents total filling of the aneurysm (>95%) as seen on the arterial phase of the cerebral angiogram (worse outcome; minimum score).
Measured: 12 months
Aneurysm occlusion - Modified Raymond Roy Classification (MRRC; short-term)
Proportion of aneurysms with Class 1 occlusion. Class 1 indicates complete obliteration of the aneurysm neck, representing complete aneurysm occlusion (better outcome; maximum score). Class 3b indicates residual aneurysm with contrast along aneurysm wall, representing substantial blood flow into the aneurysm, poor occlusion of aneurysm neck (worst outcome; minimum score).
Measured: 6 months
Aneurysm occlusion - Modified Raymond Ray Classification (MRRC; long-term)
Proportion of aneurysms with Class 1 occlusion. Class 1 indicates complete obliteration of the aneurysm neck, representing complete aneurysm occlusion (better outcome; maximum score). Class 3b indicates residual aneurysm with contrast along aneurysm wall, representing substantial blood flow into the aneurysm, poor occlusion of aneurysm neck (worst outcome; minimum score).
Measured: 12 months
Aneurysm occlusion - In-stent stenosis (ISS; short-term)
Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia. Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).
Measured: 30 days
Aneurysm occlusion - In-stent stenosis (ISS; short-term)
Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia.Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).
Measured: 90 days
Aneurysm occlusion - In-stent stenosis (ISS; long-term)
Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia.Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).
Measured: 6 months
Aneurysm occlusion - In-stent stenosis (ISS; long-term)
Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia.Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start30 May 2019
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gold Coast Hospital and Health Service
- Sponsor type
- Other government
- Collaborators
- Prince of Wales Hospital, Sydney, Liverpool Hospital, Sydney, Sir Charles Gairdner Hospital
- Responsible party
- Sponsor
- Investigators
- Henry (Hal) A Rice MBBS FRANZCR, Study director, Gold Coast University HospitalLaetitia E de Villiers MBCHB FRANZCR, Principal investigator, Gold Coast University HospitalJason D Wenderoth BSc MBBS (Hons 1) FRANZCR, Principal investigator, Prince of Wales Hospital, Shatin, Hong KongAlbert Chiu MBBS (Hons.) FRANZCR, Principal investigator, Sir Charles Gardiner HospitalNathan Manning BApSci, BSci(Hons) MBBS FRANZCR CCINR, Principal investigator, Liverpool Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815149
- Sponsor's protocol ID
- GCMR0002
- Other IDs
- ISR-2017-10909
- Acronym
- SCOPE-AUS
- Status last verified
- Dec 2019
- First submitted
- 6 Oct 2018
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: This study will comply with the Australian Government Data Sharing Policy, the NHMRC Open Access Policy and the Clinical Trials Registration and Results Information Submission rule.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Clinical Effectiveness of Pipeline™ Flex Embolization Devices With Shield Technology™ in Patients With Intracranial Aneurysms: a Multicentre Retrospective Study of an Australian Cohort (SCOPE-AUS)
- ClinicalTrials.gov ID
- NCT03815149
- Acronym / sponsor ID
- SCOPE-AUS / GCMR0002
- Conditions
- Intracranial Aneurysm, Cerebral Aneurysm, Subarachnoid Hemorrhage, Stroke, Acute, Cerebral Hemorrhage, Cerebral Stroke
- Keywords
- Interventional Neuroradiology, Diagnostic neuroradiology, Neurosurgery, Neurovascular Devices, Flow Diversion Device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Gold Coast Hospital and Health ServiceOther government
- Collaborators
- Prince of Wales Hospital, Sydney, Liverpool Hospital, Sydney, Sir Charles Gairdner Hospital
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational, retrospective, single-arm, multi-centre cohort study will use real-world data (RWD) to develop real-world evidence (RWE) of the safety and clinical effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in Australian patients that have received a flow diversion device to treat an intracranial aneurysm (IA). The medical records from 500 procedures completed at Gold Coast University Hospital in Queensland (QLD), Prince of Wales Hospital in New South Wales (NSW), and Sir Charles Gardiner Hospital in Western Australia (WA), will be analysed.
The study will report the risk and likelihood of stroke (ischaemic and haemorrhagic), delayed neurological adverse events and incomplete aneurysm occlusion within sub-groups of the patient cohort and determine the predictive or confounding factors that influence clinical outcomes under pragmatic or 'real-world' conditions.
Detailed description
Methodology summary: Single-arm, longitudinal, retrospective, multi-centre cohort study. A collaboration of Australian Interventional Neuroradiologists will create a data bank of existing clinical and angiographic data extracted from medical records review. The data collection variables are pre-specified using grading scales and clinical assessment with the greatest reliability or significant to to accurately represent patient cohorts receiving treatment within all indications of use. The study will establish a minimum dataset to collect patient socio-demographics, aneurysm characteristics, device characteristics, and clinical outcomes for up to 500 procedures completed using Pipeline™ Flex Embolization Device with Shield Technology™. A framework for data ab The prevalence, severity and outcomes of neurological adverse events of interest and bleeding events will be reported . Independent physician assessments of complete aneurysm occlusion from completed computed tomography scans (CT), Magnetic Resonance Imaging (MRI) scans and Digital Subtraction Angiography (DSA) procedures will be determined according to the Raymond Roy Occlusion Classification (MRRC), O'Kelly Marotta scale (OKM) for aneurysm occlusion using flow diverting devices and the Consensus grading scale for endovascular aneurysm occlusion up to 12 months post procedure. Assessments of wall apposition and in-stent stenosis (ISS) will also be completed.
Quality Assurance plan includes - Framework data abstraction - manual of procedures, data dictionary, data abstraction manual, desired inter-rater reliability +0.80; intrarater reliability, intraclass correlation coefficient (ICC) 0.75 - 0.9;
Medical imaging review assessed by assess aneurysm occlusion by an independent interventional neuroradiologist or a local physician operator that did not complete the primary procedure. Physician level of agreement - interrater reliability to be reported;
Independent physician review of all post-op strokes (ischaemic, haemorrhagic) cases to determine aetiology/mechanism;
Study personnel training; Site visits; remote data monitoring, data audits.
Statistical analysis plan include descriptive statistics and regression models to report prevalence, mortality, time-to-event analyses and estimations of risk; Counts of medical records with insufficient data for analysis or where the patient is identified as 'lost follow-up', this will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with intracranial aneurysm(s) | – | Device: Pipeline™ Flex Embolization Device with Shield Technology™Standard of care elective, unscheduled or emergency procedures for the treatment of an unruptured or ruptured intracranial aneurysm(s) using a Pipeline™ Flex Embolization Device(s) with Shield Technology™ |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is comprised of Australian patients aged ≥ 18 years that have received Pipeline™ Flex Embolization Devices with Shield Technology™ during a standard of care procedure to treat an IA. The patient selection period extends from 01 April 2015 to 30 June 2018.
Key inclusion criteria (3 listed)
- Patients ≥ 18 years of age
- Medical records from patients that have received a Pipeline™ Flex Embolization Device with Shield Technology™ inclusive of all indications such as an elective procedure, unscheduled procedure or emergency procedure for an unruptured or ruptured intracranial aneurysm(s) at each study site
- Medical records from patients that have received other neurovascular therapies such as coils, intracranial stents etc. with a Pipeline™ Flex Embolization Device with Shield Technology™ used as an adjunctive device during the index procedure
Key exclusion criteria (1 listed)
- Medical records from patients that have not received a Pipeline™ Flex Embolization Device with Shield Technology™ to treat an intracranial aneurysm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pipeline™ Flex Embolization Device with Shield Technology™Also: Neurointerventional procedureNeurointerventional procedures to treat intracranial (cerebral) aneurysms are minimally-invasive procedures performed by Interventional Neuroradiologists. The physician accesses the arterial system through a blood vessel in the groin followed by the insertion of a catheter. Pipeline™ Flex Embolization Device(s) with Shield Technology™,a flow diversion device, is implanted under high-magnification subtraction fluoroscopy, requiring the use of ancillary devices, such as micro-catheters and guidewires to complete the procedure under general anaesthetic. Procedural heparinisation and preloading with dual antiplatelet therapy (DAPT) using acetyl-salicylic acid and P2Y12 inhibitors such as clopidogrel or prasugrel are required. | Device | patients with intracranial aneurysm(s) |
Primary outcome
Prevalence of stroke (short-term)
Time frame: 30 days
Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
Mortality due to stroke (short-term)
Time frame: 30 days
Number of deaths due to ischaemic and haemorrhagic post procedure
Morbidity due to neurological adverse events of interest (short-term)
Time frame: 30 days
Prevalence of neurological adverse events of interest post procedure
Prevalence of stroke (long-term)
Time frame: 12 months
Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
Morbidity due to neurological adverse events of interest (long-term)
Time frame: 12 months
Prevalence of neurological adverse events of interest post procedure
Mortality due to stroke (long-term)
Time frame: 12 months
Number of deaths due to ischaemic and haemorrhagic post procedure
Mortality due to neurological adverse events of interest (long-term)
Time frame: 12 months
Deaths due to other neurological adverse events of interest
All cause mortality
Time frame: 12 months
Deaths due to any cause
11 secondary outcomes
Aneurysm occlusion - Wall apposition
Time frame: Day 0
Aneurysm occlusion - Consensus grading scale for endovascular occlusion (short-term)
Time frame: 6 months
Aneurysm occlusion - Consensus grading scale for endovascular occlusion (long-term)
Time frame: 12 months
Aneurysm occlusion - O'Kelly Marotta Scale (OKM; short-term)
Time frame: 6 months
Aneurysm occlusion - O'Kelly Marotta Scale (OKM; long-term)
Time frame: 12 months
Aneurysm occlusion - Modified Raymond Roy Classification (MRRC; short-term)
Time frame: 6 months
Aneurysm occlusion - Modified Raymond Ray Classification (MRRC; long-term)
Time frame: 12 months
Aneurysm occlusion - In-stent stenosis (ISS; short-term)
Time frame: 30 days
Aneurysm occlusion - In-stent stenosis (ISS; short-term)
Time frame: 90 days
Aneurysm occlusion - In-stent stenosis (ISS; long-term)
Time frame: 6 months
Aneurysm occlusion - In-stent stenosis (ISS; long-term)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: Yes. This study will comply with the Australian Government Data Sharing Policy, the NHMRC Open Access Policy and the Clinical Trials Registration and Results Information Submission rule.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry (Hal) A Rice MBBS FRANZCR study director
Gold Coast University Hospital
Laetitia E de Villiers MBCHB FRANZCR principal investigator
Gold Coast University Hospital
Jason D Wenderoth BSc MBBS (Hons 1) FRANZCR principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm and Cerebral Aneurysm, run by Gold Coast Hospital and Health Service at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maame Amma P Owusu RN, BSc, MNurSt, NVRN-BC (+61 7 5687 6447, maame.owusu@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of stroke (short-term) (time frame: 30 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.